ULTRACAM

K973410 · W. Edward Johansen · EIA · Oct 8, 1998 · Dental

Device Facts

• Record ID: K973410
• Device Name: ULTRACAM
• Applicant: W. Edward Johansen
• Product Code: EIA · Dental
• Decision Date: Oct 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The intraoral camera system, Ultracam, of Dental Vision Direct, Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.

Device Story

Ultracam is an intraoral camera system used by dentists in clinical settings. It captures visual images of the oral cavity; these images are displayed to patients to facilitate communication regarding dental procedures and to demonstrate treatment outcomes. The device serves as a visual aid for patient education and consultation.

Clinical Evidence

No clinical data provided; device is a visual imaging system for patient education.

Technological Characteristics

Intraoral camera system; consists of camera hardware and accessories for image acquisition and display.

Indications for Use

Indicated for use by dentists to visualize the oral cavity for patient education, procedure description, and demonstration of pre- and post-treatment results.

Regulatory Classification

Identification

A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 8 1998

> Mr. W. Edward Johansen 11661 San Vicente Boulevard Los Angeles, California 90049

Re : K973410 Trade Name: Ultracam Regulatory Class: I Product Code: EIA Dated: July 22, 1998 Received: July 24, 1998

Dear Mr. Johansen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਮੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Johansen

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## PREMARKET NOTIFICATION

## INDICATIONS FOR USE

510 (k) Number: ______________________________________________________________________________________________________________________________________________________________

Device Name: Ultracam, intraoral camera system and accessories Indications for Use:

The intraoral camera system, Ultracam, of Dental Vision Direct, Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.

Concurrence of CDRH, Office of Device Evaluation (GDR)

Healen Shurter

(Division Siga-Orf) Division of Denal, Infection Control, and General Finspital Devices 510(k) Number

Prescription Use :

OR

Over-The-Counter-Use : _

(Per 21 CER 801_109